Stenosis

New Real-World Study on Retrograde Instillation of JELMYTO® for Treatment of Low-Grade Upper Tract Urothelial Cancer Reports Similar Complete Response Rate and Lower Stricture Rate Compared to OLYMPUS Pivotal Trial

Retrieved on: 
Samstag, Mai 4, 2024
Oncology, Health, Surgery, Clinical Trials, Pharmaceutical, Biotechnology, FDA, Stenosis, Administration, Full, Ureteroscopy, Safety, UTUC, American Urological Association, Obstruction, OLYMPUS, Patient, Clutch (eggs), Mitomycins, FRCS, Neoplasm

The study includes a stepwise approach to retrograde administration of JELMYTO and reports that retrograde administration of JELMYTO in the clinic (n=20) produced a 60% complete response rate in patients and ureteral stents were placed in 25% of patients, which is lower than the rate reported in the pivotal OLYMPUS study.

Key Points: 
  • The study includes a stepwise approach to retrograde administration of JELMYTO and reports that retrograde administration of JELMYTO in the clinic (n=20) produced a 60% complete response rate in patients and ureteral stents were placed in 25% of patients, which is lower than the rate reported in the pivotal OLYMPUS study.
  • In the OLYMPUS study 58% (n=41) of patients achieved a complete response, defined as the absence of tumor lesions 3 months after initiation of JELMYTO treatment assessed by urine cytology and ureteroscopy.
  • For additional information about the retrograde administration of JELMYTO, consult the JELMYTO Instructions for Administration accompanying the Full Prescribing Information.
  • Three patients who were unable to tolerate the retrograde approach had antegrade administration of JELMYTO via a nephrostomy tube.

Facet Replacement Fda Study Garners Best Paper Award At Lumbar Spine Research Society Meeting

Retrieved on: 
Donnerstag, Mai 2, 2024
Stenosis, FDA, Patient, Spine, Spinal stenosis, Back pain, MD, Research, LSRS, Spondylolisthesis, Sciatica, Spinal fusion, Hypoesthesia, Annual general meeting, Quality of life, Walking, Overalls, CE

NORWALK, Conn., May 2, 2024 /PRNewswire-PRWeb/ --Premia Spine, a leader in innovative spinal treatment solutions, today announced that the pioneering study titled "Lumbar Facet Arthroplasty for Degenerative Spondylolisthesis with Stenosis: Interim Analysis of Three-Year Outcomes from a Prospective Randomized Clinical Trial" has been awarded the prestigious Best Paper at the Lumbar Spine Research Society (LSRS) 2024 Annual Meeting. The award-winning study, reported by Zachariah Pinter, MD, showcased the significant advantages of facet replacement over traditional lumbar fusion.

Key Points: 
  • Premia Spine's study on the TOPS® System, showcasing its advantages over traditional lumbar fusion, received the Best Paper award at the LSRS 2024 Annual Meeting.
  • NORWALK, Conn., May 2, 2024 /PRNewswire-PRWeb/ --Premia Spine, a leader in innovative spinal treatment solutions, today announced that the pioneering study titled "Lumbar Facet Arthroplasty for Degenerative Spondylolisthesis with Stenosis: Interim Analysis of Three-Year Outcomes from a Prospective Randomized Clinical Trial" has been awarded the prestigious Best Paper at the Lumbar Spine Research Society (LSRS) 2024 Annual Meeting .
  • The award-winning study, reported by Zachariah Pinter, MD, showcased the significant advantages of facet replacement over traditional lumbar fusion.
  • The research involved 300 patients who were prospectively randomized across thirty-seven centers to receive either the Total Posterior Spine (TOPS) facet joint replacement system or a TLIF lumbar fusion.

Heart-Valve-Surgery.Com and Medtronic Launch Novel "Aortic Stenosis Patient Activation Platform" to Empower Patients

Retrieved on: 
Donnerstag, April 25, 2024
Education, Patient, Stenosis, Social media, Dizziness, Aortic stenosis, Artificial intelligence, Cardiology, MetroHealth, SAVR, Senior, TAVR, Fatigue, Physician, Surgery, Aortic valve, Chest pain, Cardiovascular disease, Heart, Medical device

LOS ANGELES, April 25, 2024 /PRNewswire/ -- Heart-Valve-Surgery.com , a leading patient advocacy group for heart valve disease, with support from Medtronic , a global leader in healthcare technology, today launched the "Aortic Stenosis Patient Activation Platform", an end-to-end digital platform for patient awareness, patient education, and patient activation specific to aortic valve stenosis.

Key Points: 
  • LOS ANGELES, April 25, 2024 /PRNewswire/ -- Heart-Valve-Surgery.com , a leading patient advocacy group for heart valve disease, with support from Medtronic , a global leader in healthcare technology, today launched the "Aortic Stenosis Patient Activation Platform", an end-to-end digital platform for patient awareness, patient education, and patient activation specific to aortic valve stenosis.
  • Aortic stenosis is a narrowing of the aortic valve which prevents the aortic leaflets from opening and closing properly.
  • Patients with aortic stenosis often have heart murmurs and experience debilitating symptoms including chest pain, dizziness, fatigue, shortness of breath and an irregular heartbeat.
  • Because treatment continues to increase and evolve, the "Aortic Stenosis Patient Activation Platform", developed by Heart-Valve-Surgery.com with support from Medtronic and a world-renowned team of physicians, will increase awareness and education for aortic stenosis patients.

Silk Road Medical Strengthens TCAR Portfolio with Launch of ENROUTE Transcarotid Neuroprotection System PLUS

Retrieved on: 
Dienstag, April 2, 2024
Neuroprotection, Risk, Stroke, FSVS, NPS, Workflow, Stenosis, FACS, SILK, Blood, Physician, TCAR

SUNNYVALE, Calif., April 02, 2024 (GLOBE NEWSWIRE) -- Silk Road Medical, Inc. (Nasdaq: SILK), a company focused on reducing the risk of stroke and its devastating impact, today announced the launch of its ENROUTE® Transcarotid Neuroprotection System PLUS (“NPS PLUS”), a key component of the TCAR® portfolio.

Key Points: 
  • SUNNYVALE, Calif., April 02, 2024 (GLOBE NEWSWIRE) -- Silk Road Medical, Inc. (Nasdaq: SILK), a company focused on reducing the risk of stroke and its devastating impact, today announced the launch of its ENROUTE® Transcarotid Neuroprotection System PLUS (“NPS PLUS”), a key component of the TCAR® portfolio.
  • This next generation device builds upon the prior ENROUTE Transcarotid Neuroprotection System to deliver smoother arterial sheath insertion, greater flow precision, and a simplified prep experience for surgical teams, all while maintaining unparalleled neuroprotection during the TCAR procedure.
  • “With the launch of the NPS PLUS, we're thrilled to empower our TCAR-trained physicians with a solution that addresses their insights and feedback to further strengthen and streamline the TCAR procedure,” shared Chas McKhann, Chief Executive Officer of Silk Road Medical.
  • During TCAR, the surgical team inserts a tube-like sheath into the carotid artery and connects it to the ENROUTE Neuroprotection System, which temporarily reverses blood flow.

Johnson & Johnson to Acquire Shockwave Medical

Retrieved on: 
Freitag, April 5, 2024
Research, Medical Devices, Health Technology, Cardiology, Biotechnology, Other Health, Health, Pharmaceutical, Science, Cardiovascular disease, Worldwide, Growth, Peripheral artery disease, Coronary artery disease, Johnson & Johnson, Patient, PAD, JNJ, Perella Weinberg Partners, Acquisition, Electrophysiology, Death, IVL, Medtech, Ventricular fibrillation, European, PCI, Artery, Laminar, Stenosis, Hand, Physician, Percutaneous coronary intervention, CAD, Pharmaceutical industry

Johnson & Johnson (NYSE: JNJ) and Shockwave Medical, Inc. (Nasdaq: SWAV) (“Shockwave”) today announced that they have entered into a definitive agreement under which Johnson & Johnson will acquire all outstanding shares of Shockwave for $335.00 per share in cash, corresponding to an enterprise value of approximately $13.1 billion including cash acquired.

Key Points: 
  • Johnson & Johnson (NYSE: JNJ) and Shockwave Medical, Inc. (Nasdaq: SWAV) (“Shockwave”) today announced that they have entered into a definitive agreement under which Johnson & Johnson will acquire all outstanding shares of Shockwave for $335.00 per share in cash, corresponding to an enterprise value of approximately $13.1 billion including cash acquired.
  • The transaction is expected to accelerate revenue growth for both Johnson & Johnson and Johnson & Johnson MedTech.
  • Delivers immediate operational accretion: The transaction will be accretive to operating margin for both Johnson & Johnson and Johnson & Johnson MedTech.
  • Under the terms of the agreement, Johnson & Johnson will acquire all outstanding shares of Shockwave for $335.00 per share in cash through a merger of Shockwave with a wholly owned Johnson & Johnson subsidiary.

Cleerly® ISCHEMIA™ Demonstrates Robust Diagnostic Accuracy and Prognostic Utility in Analyses from Large Scale Clinical Trials

Retrieved on: 
Donnerstag, März 28, 2024
FDA, Health, Technology, Clinical Trials, Artificial Intelligence, Cardiology, Diagnosis, Coronary ischemia, Patient, Myocardial perfusion imaging, Journal, Ischemia, MD, American College, CCTA, Stenosis, Atherosclerosis, SPECT, Medical device

The study describes the validation of Cleerly's artificial intelligence-guided quantitative coronary CT angiography (AI-QCT) ISCHEMIA technology for diagnostic accuracy and prognostic risk stratification.

Key Points: 
  • The study describes the validation of Cleerly's artificial intelligence-guided quantitative coronary CT angiography (AI-QCT) ISCHEMIA technology for diagnostic accuracy and prognostic risk stratification.
  • For patients with an abnormal Cleerly AI-QCT ISCHEMIA finding, a positive result was associated with an approximately 7-fold increase of adverse cardiovascular events during an 8-year follow-up.
  • Collectively, this study shows that Cleerly AI-QCT ISCHEMIA, when used in conjunction with Cleerly LABS, can provide a 3-in-1 approach for the assessment of atherosclerosis, stenosis and ischemia.
  • These study results come after Cleerly announced that its Cleerly ISCHEMIA software device is billable using the new Category I CPT® code 75580.

Innovating "Treadmill Exercise Test AI-Assisted Interpretation System," CMUH(Taiwan) Timely Saves More Patients with Severe Myocardial Infarction

Retrieved on: 
Dienstag, April 2, 2024
Depression, Thrombosis, Myocardial infarction, Sudden death, Cardiovascular disease, Exercise, Survival, Coronary artery disease, ECG, Hyperlipidemia, Patient, Palpitations, Angina, Cancer, AI, Death, Moyamoya disease, Chronic pain, Plaque, Diet, Receiver, Smoking, Cardiac catheterization, Stenosis, Oxygen, Heart, Atherosclerosis, Rupture, Ministry, Duke, Vascular occlusion, CAD

To address this issue, China Medical University Hospital (CMUH) AI Center successfully developed the "Treadmill Exercise Test AI-Assisted Interpretation System" which was trained with nearly a thousand treadmill ECG, in patients with coronary arterystenosisover 70% shown on their coronary angiography.

Key Points: 
  • To address this issue, China Medical University Hospital (CMUH) AI Center successfully developed the "Treadmill Exercise Test AI-Assisted Interpretation System" which was trained with nearly a thousand treadmill ECG, in patients with coronary arterystenosisover 70% shown on their coronary angiography.
  • The program also utilizes ten measured features and two derived features including maximal work output and peak heart rate to determine the severity of coronary artery stenosis.
  • Generally, coronary heart disease in patients of middle or senior age is presented as angina or myocardial infarction and is one of the primary causes of sudden death."
  • Dr. Wu stated, "Coronary artery stenosis is a multi-factorial condition related to smoking, advanced age, diabetes hypertension and hyperlipidemia.

InspireMD Reports Fourth Quarter and Full-Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Mittwoch, März 6, 2024
CMS, Pi, Growth, Radiology, IDE, State university system, CAD, Buffalo, PMA, MDR, TEL, Medical device regulation, Health, Stroke, CAS, TCAR, EPS, EFS, Thomas Jefferson University, European, Carotid artery stenosis, Myocardial infarction, CE marking, Vascular disease, Thrombectomy, Clinical trial, Medicaid, NPS, CEA, Good Samaritan Hospital, Stenosis, Risk, Blood vessel, Medicare, Death, Stent, Patient, Medicine, NSPR, Pharmaceutical industry

TEL AVIV, Israel and MIAMI, March 06, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the treatment of carotid artery disease (CAD) and prevention of stroke, today announced financial and operating results for the fourth quarter and full-year ended December 31, 2023.

Key Points: 
  • Fourth Quarter 2023 and Recent Developments:
    Generated record CGuard revenue in the fourth quarter 2023 of $1.76 million, a 71.6% increase over the fourth quarter of 2022.
  • Sold 3,107 CGuard EPS stent systems in the fourth quarter of 2023, as compared to 1,781 in the fourth quarter of 2022, an increase of 74.5%.
  • Financial Results for the Fourth Quarter Ended December 31, 2023
    For the fourth quarter of 2023, total revenue increased 71.6%, to $1,761,000, from $1,026,000 during the fourth quarter of 2022.
  • Total financial income for the fourth quarter of 2023 was $468,000, an increase of $349,000 or 293% compared to $119,000 for the third quarter of 2022.

Silk Road Medical Expands TCAR® Portfolio with Launch of Tapered ENROUTE® Transcarotid Stent System

Retrieved on: 
Dienstag, März 5, 2024
FACS, Hospital, MD, CEA, Professor, Physician, Vascular surgery, Stroke, Plaque, MBA, Risk, Cooper University Hospital, Silk, Patient, Anatomy, TCAR, Stenosis, SILK, Pharmaceutical industry

This launch expands upon the company’s prior ENROUTE Transcarotid Stent System, offering additional configurations to better tailor the Transcarotid Artery Revascularization (TCAR) procedure to patient anatomy.

Key Points: 
  • This launch expands upon the company’s prior ENROUTE Transcarotid Stent System, offering additional configurations to better tailor the Transcarotid Artery Revascularization (TCAR) procedure to patient anatomy.
  • “New tapered configurations for our ENROUTE Transcarotid Stent System build upon the robust portfolio of Silk Road’s carotid solutions.
  • The ENROUTE Transcarotid Stent System features an optimized cell design balancing lesion coverage and anatomical conformability for long-term plaque stabilization.
  • The stent system was purpose-built for TCAR with a short delivery system for ergonomic and precise stent delivery.

Exclusive license agreement secured with Erganeo for EVerGel, EVerZom's first drug candidate, a breakthrough treatment for fistulas and fibrosis of the digestive tract.

Retrieved on: 
Dienstag, März 5, 2024
CNRS, Regeneration, Crohn's disease, EIC, Exosome, Quality of life, Fistula, Stenosis, B cell, Patient, Fibrosis, Intellectual property, Congress, Research, ECCO, Pharmaceutical industry

Exclusive license agreement secured with Erganeo for EVerGel, EVerZom's first drug candidate, a breakthrough treatment for fistulas and fibrosis of the digestive tract.

Key Points: 
  • Exclusive license agreement secured with Erganeo for EVerGel, EVerZom's first drug candidate, a breakthrough treatment for fistulas and fibrosis of the digestive tract.
  • This new worldwide license marks a significant step forward in EVerZom's mission to bring innovative exosome-based therapeutic solutions to patients suffering from serious digestive diseases.
  • Paris, March 5, 2024 - EVerZom, a CNRS/Université Paris Cité spin-off specializing in exosomes, has announced the signature of a second exclusive license agreement with Erganeo for the development of EVerGel ™, a drug candidate tailored for the healing of digestive tissues.
  • EVerZom's first clinical application focuses on digestive tissue regeneration using naive exosomes derived from stem cells encapsulated in a gel called EVerGel ™.